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Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy

RecruitingObservational study

Who can join

Up to age 26 · All sexes

Full eligibility criteria
Inclusion Criteria (Arm A)

\* Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma

Who either:

* Experienced refractory or relapsed disease, treated with standard chemotherapy, without immunotherapy treatment.

OR

* Previously undergone standard of care immunotherapy with FDA approved therapies, such as Kymriah™ (CTL019, tisagenlecleucel), blinatumomab or

  * Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age.

Inclusion Criteria (Arm B)

* Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
* Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age
* Patients who are either:

  * Undergoing evaluation for leukapheresis for planned standard of care tisagenlecleucel therapy, or planned for therapy with blinatumomab or inotuzumab. (Patients who received prior tisagenlecleucel, blinatumomab or inotuzumab on an established clinical trial and are now scheduled for commercial CAR, blinatumomab or inotuzumab therapy are also eligible) Or
  * Experienced refractory or relapsed B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
* Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent or have legal authorized representative (LAR) (i.e. parent or guardian) to consent, if not in capacity to give consent independently. For subjects \<18 years old their LAR must give informed consent. Pediatric subjects will be included in age appropriate discussion and written assent will be obtained for those \> 7 years of age, when appropriate, according to institutional procedures.

About the study

To use a consistent and standardized platform to retrospectively and prospectively study children and young adults with B cell malignancies receiving Immunotherapy, blinatumomab and/or inotuzumab ozogamicin.

What is being tested

Sponsor: Stanford University · Participants: 500 · Started: Jun 29, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05865301

Locations in the U.S.

ArizonaBanner University Medical Center - Tucson, Tucson
CaliforniaCity of Hope Comprehensive Cancer Center, Duarte
Stanford University, Palo Alto
UCSF (Benioff Children's), San Francisco
DelawareNemours Children's Hospital, New Castle
FloridaUniversity of Florida Health Science Center - Gainesville, Gainesville
Johns Hopkins All Children's Hospital, St. Petersburg
IllinoisAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago
MarylandJohns Hopkins University/Sidney Kimmel Cancer Center, Baltimore
MassachusettsDana-Farber Cancer Institute, Boston
MichiganCorewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids
MissouriSt. Louis Children's (Washington University), St Louis
New YorkChildren's Hospital at Montefiore, The Bronx
North CarolinaAtrium Health Levine Cancer Institute, Charlotte
OhioCincinnati Children's Hospital Medical Center, Cincinnati
OregonOHSU Knight Cancer Institute, Portland
PennsylvaniaChildren's Hospital of Pittsburgh of UPMC, Pittsburgh
TexasUT Southwestern/Simmons Cancer Center-Dallas, Dallas
Cook Children's Medical Center, Fort Worth
VirginiaSaint Jude Children's Research Hospital, Fairfax
WashingtonSeattle Children's Hospital, Seattle
WisconsinMedical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.